Cerebellar Transcranial Alternating Current Stimulation (tACS) to Modulate Parkinson's Disease Tremor

ConditionsParkinson's Disease (PD)Tremor

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversitätsklinikum Hamburg-Eppendorf

About this trial

Parkinson's disease (PD) is a prevalent neurodegenerative disorder characterized by different motor symptoms, including tremor, which is particularly difficult to manage. Common treatments, such as dopaminergic therapy, can have limitations in efficacy. Recent advancements in non-invasive brain stimulation, specifically phase-adaptive transcranial alternating current stimulation (tACS), offer a promising approach to reduce PD tremor. In the current project, a newly developed closed-loop system delivers precisely synchronized cerebellar tACS by aligning stimulation with the intrinsic hand tremor signal. The study will assess the efficacy of this novel approach to reduce hand tremor in PD patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of Parkinson's disease based on UK Brain Bank criteria

Patient exhibiting moderate to severe hand tremor

Provision written informed consent by the patient

Disqualifiers

History of other neurological disorders such as vascular malformations, ischemic or haemorrhagic stroke, cerebral neoplasia, epilepsy, or major psychiatric illness

Existence of heart pacemaker or metal implants in the body

Pregnancy

Trial design

Design model

Crossover

Treatments tested in this trial

Active-tACS
Device
30 seconds of closed-loop tACS at 2-4 mA, with 6 alternating phase alignments and 1-3 repetitions. Phase alignment is adjusted to the patient's tremor frequency and rhythm in real time. Administered using the neuroConn LOOPIT device and 2 electrodes placed on the cerebellum and jaw, with an area of 5x5 and 5x7 respectively. The stimulation begins with a 3-second ramp-up and ends with a 3-second ramp-down.
Sham-tACS
Device
30 seconds of tACS at 0 mA and 1-3 repetitions. Administered using the neuroConn LOOPIT device and 2 electrodes placed on the cerebellum and jaw, with an area of 5x5 and 5x7 respectively. The sham protocol begins with a 3-second ramp-up and ends with a 3-second ramp-down.
Unlocked-tACS
Device
30 seconds of open-loop tACS at 2-4 mA, with no phase alignments and 1-3 repetitions. Administered using the neuroConn LOOPIT device and 2 electrodes placed on the cerebellum and jaw, with an area of 5x5 and 5x7 respectively. The stimulation begins with a 3-second ramp-up and ends with a 3-second ramp-down.

Treatment groups

10 Participants

are divided into 3 treatment groups

Group A: Active-tACSExperimental treatment 1 intervention

Group B: Sham-tACSSham comparator 1 intervention

Group C: Unlocked-tACSActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change in tremor amplitude

A significant change in the amplitude of hand tremor as the active tACS stimulation with the optimum phase alignment is being delivered. Tremor amplitude is computed offline in MATLAB.

Time frame

During the stimulation

Secondary outcomes

Tremor entrainment

Changes in tremor characteristics including instantaneous frequency due to active stimulation

Time frame

During the stimulation

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitätsklinikum Hamburg-Eppendorf

Lead sponsor

Source ClinicalTrials.gov

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